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SILibinin in NSCLC and BC Patients With Single Brain METastasis (SILMET) — SILMET  

Breast Cancer Clinical Trial

Official title:
A Phase 2 Randomized, Multicenter Trial on Silibinin To Prevent Intracranial Recurrence After Gross-Total Resection of Single Brain Metastasis From Non-Small Cell Lung Cancer or Breast Cancer

Clinical Trial Summary

This study aims to evaluate the efficacy of silibinin in preventing recurrence in the brain after complete resection of a brain metastasis (BM) from non-small-cell lung cancer (NSCLC) or breast cancer (BC).

Clinical Trial Description

This is the first placebo-controlled study evaluating the efficacy of silibinin as STAT3 inhibitor in preventing recurrence in the brain after gross-total resection of a brain metastasis (BM) from non-small-cell lung cancer (NSCLC) or breast cancer (BC). Participants will be randomized 1:1 to silibinin 1 g/day taken orally in comparison with oral placebo 1 g/day. A contrast-enhanced brain MRI will be performed every 8 weeks to evaluate intracranial local and distance recurrence ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05689619
Study type Interventional
Source Azienda Ospedaliera Città della Salute e della Scienza di Torino
Contact Pierangela Botta
Phone +390116334904
Email botta.neuro.oncologia@gmail.com
Status Recruiting
Phase N/A
Start date September 1, 2023
Completion date September 1, 2027
View Details
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